Efficacy of Laser Hair Removal Therapy in HS (HaLa)

The Efficacy of Laser Hair Removal Therapy in Patients With Mild to Moderate HS, a Randomized Controlled Trial.

Hidradenitis suppurativa (HS) is a chronic, recurrent and debilitating inflammatory skin disorder, characterized by painful inflamed nodules, abscesses and tunnels in the skin folds such as the axilla, inguinal region and gluteal area. The primary event in HS is occlusion of the hair follicle. HS is a notoriously difficult to treat disease, because treatment options are limited and evidence based treatments are scarce. Prevention of diseases is an important topic in medicine. However, current clinical trials in HS are focusing on anti-inflammatory drugs in patients with severe HS, whereas prevention and treatment of patients with more common mild HS is neglected. Laser hair removal therapy is a non-invasive procedure with minimal treatment discomfort for patients. Previous limited studies have suggested positive results in favor of laser hair removal therapy in HS. We therefore hypothesize that hair depilation using laser hair removal therapy may prevent the formation of new lesions and flares of the disease. The objective is to assess the efficacy of laser hair removal therapy in patients with mild to moderate HS.

Study Overview

• Status: Not yet recruiting
• Conditions: Hidradenitis Suppurativa, Acne Inversa
• Intervention / Treatment: Procedure: Nd:YAG laser hair removal; Drug: Clindamycin 1 % Topical Lotion

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hessel van der Zee, MD, PhD; Phone Number: +31 10 704 0110; Email: h.vanderzee@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• IHS4 mild to moderate, without tunnels in the axillae.
• HS activity in at least one axilla.
• Age 18 years and over.

Exclusion Criteria:

• If the patient is not able or willing to provide informed consent.
• If the patient is allergic to clindamycin lotion.
• If the patient uses systemic therapy for HS such as antibiotics or biologicals.
• If a patient is pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group, laser hair removal therapy; Patients will undergo 6 monthly laser hair removal treatments with de Nd:YAG laser. After 6 months, a 6 follow up will start, using clindamycin 1% lotion if needed.	Procedure: Nd:YAG laser hair removal; Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.
Active Comparator: Control group, clindamycin 1% lotion if needed, standard care; Patients will use clindamycin 1% lotion of needed for 1 year.	Drug: Clindamycin 1 % Topical Lotion; Clindamycin 1% lotion if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in IHS4 over time, measured between month 7 to month 12	The IHS4 will be assessed monthly.	between month 7 to 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative IHS4 over month 7 to month 12 between the two groups	IHS4 will be calculated on a monthly bases. IHS4 will be added up per visit which makes it a cumulative outcome	month 7 to 12
Change in skin related pain of the axillae, on a numerical rating scale (NRS), between baseline and month 12, and between groups.	NRS pain will be assessed	every month for 12 months
Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.	NRS itch will be assessed	every month for 12 months
Difference in number of self-reported flares (number of flares reported by the patients in the last 4 weeks), between the two groups during this study	Number of self reported flares will be assessed	every month for 12
Difference and change in quality of life measured with the Dermatologic Life Quality Index (DLQI) between baseline and month 12 and between groups.	PROM will be assessed	every month for 12 months
Difference and change in quality of life measured with the Hidradenitis Suppurativa Quality of Life score (HiSQOL), between baseline and month 12 and between groups.	PROM will be assessed	every month for 12 months
Difference in patients satisfaction score at month 12 between groups.	patients satisfaction will be assessed	every month for 12 months
Cumulative IHS4 over month 7 to 12, correlated to hair loss after six months.	the amount of hair loss will be assessed and correlated to the cumulative IHS4	every month for 12 months
Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups.	The cumulative IHS4 will be assessed after 3, 9 and 12 months	every month for 12 months
Difference in pustule and papule count during visits over month 1 to 12 between groups.	the number of papules and pustules will be assessed	every month for 12 months
Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.	number of abscesses and nodules will be assessed	every month for 12 months
Difference in number of times escape medication has been used over month 1 to 12 between groups.	Number of escape medication will be assessed	every month for 12months
Difference of average duration of a flare, reported by the patient, over month 1 to 12 between groups.	Duration of a flare will be assessed	every month for 12 months
The difference in IHS4 and HS-PGA, measured every visit.	The IHS4 and HS-PGA will be assessed	every month for 12 months
Amount of clindamycin lotion use for both groups.	clindamycin 1% lotion will be weighted every visit	every month for 12 months
Difference in number of adverse events between groups.	safety will be assessed using adverse events	every month for 12 months
Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study.	safety will be assessed using adverse events	every month for 12 months
Histopathological: diameter hair shaft in axillary skin before and after treatment.	Biopsies will be taken for histopathological research	Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
Histopathological: plugging of the hair follicle in the skin before and after treatment	Biopsies will be taken for histopathological research	Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
Histopathological: immunohistochemistry in the skin before and after treatment	Biopsies will be taken for histopathological research	Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
Histopathological: AMP expression in the skin before and after treatment	Biopsies will be taken for histopathological research	Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Hessel van der Zee, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Estimate): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: laser hair removal therapy
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
• Other Study ID Numbers: EMCD_22026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No